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N/A Aq-F-10-31

by Summit Medical, LLC

Ref AQ-F-10-31

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number03856492982_DENVERSPNKNL Basic UDI-DI 00385640045926UDI-DIDate26 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00385640045926 UDI-DI Date27 Jul 2019ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
The Denver Splint Thermoplastic
Generic Name
External nasal splint
Device Name
The Denver Splint (Non-Kit)
Model / Reference
AQ-F-10-31
Primary DI / UDI-DI
00385640045926
Basic UDI-DI
03856492982_DENVERSPNKNL
FDA Product Code
EPP
EMDN Code
P020203 Nasal splints
GMDN Term
External nasal splint
Device Class
Class I
Regulation Number
874.5800
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Related devices

Category: External nasal splint

Other devices from Summit Medical, LLC

See all devices from Summit Medical, LLC →

Properties

  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (19)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No